Nimbus Probe (Disposable)

GUDID 05060224336649

Disposable RF Thermocouple Electrode

Stratus Medical LLC

Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
Primary Device ID05060224336649
NIH Device Record Keydce84fa0-6bae-4b29-82e4-3bc430c41503
Commercial Distribution StatusIn Commercial Distribution
Brand NameNimbus Probe (Disposable)
Version Model NumberNDP-150-27-SS-CE
Company DUNS117402924
Company NameStratus Medical LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060224331750 [Primary]
GS105060224336649 [Package]
Contains: 05060224331750
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXIProbe, Radiofrequency Lesion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-21
Device Publish Date2022-09-13

On-Brand Devices [Nimbus Probe (Disposable)]

05060224336939Disposable RF Thermocouple Electrode
05060224336922Disposable RF Thermocouple Electrode
05060224336915Disposable RF Thermocouple Electrode
05060224336649Disposable RF Thermocouple Electrode
05060224336632Disposable RF Thermocouple Electrode
05060224336625Disposable RF Thermocouple Electrode
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